Interesting news regarding a prodigious effort by Novartis to develop new vaccines for neglected diseases. Below is the media release by the company. I wonder what people think about Pharma's role in vaccine/drug development for neglected diseases?
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Basel, February 22, 2008 - Novartis today announced the opening of a new research institute in Siena with a nonprofit mission to exclusively focus on the development of vaccines for diseases of the developing world. The Novartis Vaccines Institute for Global Health (NVGH) is the first institute of its kind to be set up by a major vaccine manufacturer.
The NVGH's goal is to address the unmet medical need for vaccines for diseases of the developing world by researching vaccines specifically tailored for developing country needs and introducing them first in those countries. The NVGH is a public private partnership and will also collaborate with external organizations to build strength in resources.
The institute will be headed by Allan Saul, who has nearly 30 years of experience in translational research and development. Dr. Saul joined Novartis from the laboratory of Malaria and Vector Research at the National Institute of Allergy and Infectious Diseases in the US. He has a strong background in vaccines research and his translational vaccine research experience has lead to numerous candidates taken into full development and testing.
"NVGH reinforces the Novartis commitment to R&D for neglected diseases, and will potentially bring innovative vaccines to the patients who may need it most," said Dr. Daniel Vasella, Chairman and CEO of Novartis. "Novartis will continue to draw on our expertise and the skills of our associates to contribute to sustainable Corporate Citizenship initiatives."
Research activities at NVGH, which will be part of the Novartis overarching Corporate Research program, will leverage the existing Novartis Vaccines research expertise and innovative technology platforms that add significant value and speed to bringing these vaccines forward. The institute's strategic location in Siena also enables researchers to utilize the scientific know-how and experience of the existing Novartis Vaccines and Diagnostics global research center there, led by Rino Rappuoli, Global Head of Vaccines Research. NVGH projects will be managed separately from the commercial vaccine research projects, with a dedicated team of management, scientists and resources.
"Novartis Vaccines is already on the cutting edge of vaccines research," said Joerg Reinhardt, CEO of Novartis Vaccines and Diagnostics. "And now the opening of NVGH will allow us to apply our knowledge and expertise of vaccines research to diseases that affect the developing world. This approach will enable NVGH to play a leading role in permanently reducing the burden of neglected diseases rather."
The world faces an urgent need to develop better drugs and vaccines for diseases that are largely confined to developing countries. With one-sixth of the world's population affected by neglected diseases yet the drug and vaccine pipeline for these diseases is almost dry. Currently, only about 10% of the world's medical research is devoted to conditions that account for 90% of the global disease burden.
All products discovered at NVGH will be introduced first in developing countries. While NVGH will focus on the R&D for vaccines for diseases of the developing world, the Institute will license a third party to develop and distribute the vaccines at an affordable and accessible price to the target populations.
"NVGH will aim to become a center of excellence for vaccines for neglected diseases," says Paul Herrling, Head of Corporate Research at Novartis. "Novartis has already set-up a similar research institute dedicated to neglected tropical diseases for pharmaceutical drugs, and similarly to that, accessibility to and affordability of NVGH products will be the priority, not commercial value or profit potential."
At present, NVGH is conducting the majority of research activities around conjugate vaccines for enteric diseases. Initial disease areas of focus will be Salmonella enterica serovar Typhi (S. typhi), Salmonella paratyphi A and nontyphoidal salmonellae (NTS), which are important causes of infection and disease in children. In Africa, multidrug-resistant non-typhoidal salmonella (NTS) is one of the leading causes of morbidity and high mortality in children under 5 years of age, second in importance only to pneumococcal disease. With more than 4.5 billion cases per year, diarrheal diseases are ubiquitous around the globe.
NVGH is part of the Novartis overall commitment to corporate citizenship, and finding solutions to help close the access gap. While the fundamental aspects of healthcare provision rely on support of governments and inter-governmental agencies, Novartis plays a role whenever possible to improve patient access to our medicines.

I found a very interesting article in the Feb 8th issue of Science regarding new ways for encouraging research in academia and industry for the development of new drugs for neglected diseases. The proposal involves a large prize that would replace a patent, thus allowing access to life-saving drugs at affordable prices. The argument is that the size of the prize will determine the level of interest in research. Furthermore, another criteria which could be used to determine the size of the prize could be the number of lives saved or enhanced as a direct result of the drug/therapy. I think this is the kind of 'out-of-the-box' thinking that could yield some positive results in the long run.
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MAASTRICHT, THE NETHERLANDS--If the World Health Organization offered a $10 billion award for a malaria vaccine, would that persuade major pharmaceutical companies to go after the prize? Could a $100 million prize encourage development of a reliable, cheap, and fast diagnostic assay for tuberculosis? And would those monetary awards prove to be the cheapest, or fastest, way to achieve such medical innovations?

Provocative questions such as those were at the core of a 2-day workshop* here last week addressing whether prize incentives can stimulate the creation of new drugs and therapies. For some speakers, prizes offer a chance to spur medical research on neglected diseases, including those that strike people in developing nations who can afford little health care. Others took a more radical view: A national or global medical prize scheme could eliminate drug patents, stimulate drug development, and lower escalating health care costs. "A prize is a [research] incentive, the same way a monopoly is an incentive," says James Love, director of the think tank Knowledge Ecology International (KEI) in Washington, D.C.

Cosponsored by KEI and UNU-MERIT, a research and training center run jointly by United Nations University and Maastricht University, the workshop drew several dozen economists, intellectual-property specialists, public-health officials, and drug-development experts to discuss a concept that's attracting more attention. For example, U.S. Senator Bernie Sanders (I-VT) has introduced a bill, the Medical Innovation Prize Act, written with Love's help, that would replace medical patents with an estimated $80 billion annual award fund. Although the bill is unlikely to go anywhere now, Sanders hopes to get a Senate hearing this year to publicize the concept. "There is growing interest and political feasibility for trying prizes in a variety of contexts," says Stephen Merrill of the U.S. National Academies, who recently examined how the U.S. National Science Foundation could set up a prize system to stimulate innovation (Science, 26 January 2007, p. 446).
Prize contests have long been used to steer efforts toward particular discoveries or technological accomplishments, and they're becoming popular again (Science, 30 September 2005, p. 2153). One well-known early success was the British government's 18th century prize to find a way for seafarers to gauge longitude. More recently, the $10 million Ansari X Prize for a private, reusable, crewed spacecraft prompted an estimated $100 million to $400 million in space-flight research before Burt Rutan's SpaceShipOne won it in 2004.

Although perhaps not as prevalent as technology competitions, medical prizes are attracting sponsors. Pierre Chirac of Médecins sans Frontières said at the meeting that his group was considering an award for the desperately needed TB diagnostic test. And in 2006, Prize4Life, a nonprofit group founded by a patient with amyotrophic lateral sclerosis (ALS), announced a $1 million prize for a biomarker that can track the fatal disease's progression--a key for any drug development. Prize4Life hopes to launch two more contests, including a $2.5 million prize for a treatment that proves effective in a common mouse model of ALS.

Such modest awards pale in comparison to the mammoth prize system Love advocates through the Sanders bill. Financed annually with 0.6% of the United States's gross domestic product--about $80 billion at the moment--the Sanders plan would give annual awards to medical innovations based on the health impact for the nation--assessed using a measurement known as quality-adjusted life years that gauges improvements in life expectancy. Instead of the government granting patents to a company, a board that would include business and patient representatives, as well as government health officials, would each year judge any new products and award their developers a share of the fund.

At the Maastricht meeting, intellectual-property specialist William Fisher III of Harvard Law School argued that prize schemes have some advantages. Patents, said Fisher, guide medical research away from vaccines, which may require at most a few doses per person but arguably have the most health impact, and toward treatments for the rich and the development of "me-too" drugs, copies of an already successful drug with just enough differences to be patentable. "Prizes can offset all three" of those biases, he says.

PhRMA, a trade group in Washington, D.C., that represents pharmaceutical and biotech firms, has strongly criticized the Sanders bill as a step toward socialized medicine. And yet it is intrigued by new incentives, if the patent system stays intact. "It's an interesting idea to add prizes for neglected diseases to the existing system," says Shelagh Kerr of PhRMA, who attended the workshop.

Prize incentives are, however, unlikely to sweep the medical research world. Philanthropic and patient groups may offer new awards, but governments may be more cautious. "We're no longer in the Longitude Prize era. We pay scientists many millions to do research," says David King, former science adviser to the U.K. government. "How do you decide how much money to award?" adds economist Aidan Hollis of the University of Calgary in Canada, noting that governments typically don't know in advance what social value a medical treatment will have.

The workshop itself offered an ironic morsel of evidence that prizes are not perfect incentives. Organizers offered a €1500 award for the best paper on using monetary prizes to stimulate private investment in medical research, but no entries have been submitted thus far. The contest has now been extended to mid-April.